Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With Chronic Juvenile Arthritis (CJA) Treated by Corticosteroid Therapy

• Register: EUCTR
• Last refreshed on: 7 April 2015
• Main ID: EUCTR2014-004105-32-Outside-EU/EEA
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc
• Public title: Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With Chronic Juvenile Arthritis (CJA) Treated by Corticosteroid Therapy
• Scientific title: Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor (Genotonorm) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-Term Corticosteroid Therapy. Extension of the Study Beyond Three Years.
• Target sample size: 21
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004105-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

France

Contacts

• Name: PfizerCallCenter
• Affiliation: Pfizer Inc

• Name: PfizerCallCenter
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1. All subjects had to be previously included in Study CTN 97-8129-016 to continue somatropin treatment until FH was reached.
2. All subjects should have received corticosteroid therapy, whatever the dose or the method of administration.

Are the trial subjects under 18? yes
Number of subjects for this age range: 21
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Discontinuation of corticosteroid therapy for more than a year during Study CTN 97-8129-016.
2. Concomitant severe, chronic disease: renal failure (glomerular filtration less than or equal to [<=] 50 mililiter per min per meter [ml/mn/1m] ^2 73), nephrotic syndrome, hepatic failure, diabetes.
3. Endocrine disorder except for adequately compensated hypothyroidism.
4. Subjects withdrawing from the study prematurely.
5. Non-compliant subjects.
6. Inclusion in another protocol.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Juvenile idiopathic arthritis (JIA)

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: Genotropin
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Somatropin
Current Sponsor code: Genotropn
Other descriptive name: SOMATROPIN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5.3 -12

Primary Outcome(s)

Main Objective: To evaluate the effect of increasing the Human growth hormone (hGH) dose (0.6 versus 0.46 milligram per kilogram per week [mg/kg/week ] or 1.8 versus 1.4 international unit per kilogram per week [IU/kg/week]) on the statural response in subjects initially in the treated group of Study CTN 97-8129-016, by comparing the statural response observed with that obtained during the first therapeutic phase at a dose of 0.46 mg/kg/week, or 1.4 IU/kg/week

Primary end point(s): 1) Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3
2) Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height
3) Change From Baseline in Height Standard Deviation Score (SDS) at Year 3
4) Change From Baseline in Height Standard Deviation Score (SDS) at Final Height
5) Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3
6) Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height

Timepoint(s) of evaluation of this end point: 1) Baseline, Year 3
2) Baseline, final height (assessed up to Year 9.5)
3) Baseline, Year 3
4) Baseline, final height (assessed up to Year 9.5)
5) Baseline, Year 3
6) Baseline, final height (assessed up to Year 9.5)

Secondary Objective: To assess the value of early treatment during the course of arthritic disease by comparing
changes to the body composition and bone mineralization in the 2 groups of children.
To assess safety by monitoring of arthritic disease (clinical) and glucose tolerance
(biological).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
2) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9
3) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9
4) Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
5) Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
6)Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9

Secondary end point(s): 1) Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
2) Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9
3) Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9
4) Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
5) Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
6) Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9

Secondary ID(s)

A6281024

307-MET-9002-052

Source(s) of Monetary Support

Pfizer Inc